FDA.reportPublic FDA data

ENDURE INDUSTRIES

Primary DI
08697645018143
Brand
ENDURE INDUSTRIES
Company
ENDURE INDUSTRIES
Model
AMT6M
Catalog number
AMT6M
Device description
Anesthesia Mask Size 6
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38697645018434PackageGS140In Commercial Distribution
08697645018143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3869764501843438697645018434
08697645018143086976450181438697645018143

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
607-299-4971support@endureind.com

Regulatory Flags#

DUNS number
066087031
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840118617567Endure IndustriesECLJBSECLJBS-302026-08-03
00840118617581Endure IndustriesECLJBMECLJBM2026-08-03
00840118617604Endure IndustriesECLJBLECLJBL2026-08-03
00840118617628Endure IndustriesECLJBXLECLJBXL2026-08-03
00840118617659ENDURE INDUSTRIESELCKSELCKS2026-08-03
00840118617673Endure IndustriesELCKMELCKM2026-08-03
00840118617697Endure IndustriesELCKLELCKL2026-08-03
00840118617710Endure IndustriesELCKXLELCKXL2026-08-03
00840118617741Endure IndustriesELCKXXLELCKXXL2026-08-03
00840118617772Endure IndustriesELCTSELCTS2026-08-03
00840118617802Endure IndustriesELCTMELCTM2026-08-03
00840118620444ENDURE INDUSTRIESGSTMGSTM2026-08-03
00840118620468ENDURE INDUSTRIESGSTLGSTL2026-08-03
00840118620482ENDURE INDUSTRIESGSTXGSTX2026-08-03
00840118687690Endure IndustriesELCTLELCTL2026-08-03
00840118698399Endure IndustriesELCTXLELCTXL2026-08-03
00840118608046ENDURE INDUSTRIESNROMA11NROMA112024-04-01
00840118608060ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118611619ENDURE INDUSTRIESNROMPE11NROMPE112024-04-10
00840118611633ENDURE INDUSTRIESNROMAE11NROMAE112024-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719874951184Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
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04719874955816Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956264Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956271Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956288Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
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00607411919336Salter Labs® Percent-O2-Lock® MaskSALTER LABSBYG2026-06-10
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00607411919053Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
00607411919060Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
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04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
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10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29